Mifepristone (RU-486) in Androgen Independent Prostate Cancer
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to determine the effects (good and bad) that mifepristone has on patients with androgen independent prostate cancer.
Full description
Patients will receive mifepristone, 200mg orally once a day. One treatment cycle is 28 days long. Patients will remain on treatment unless their cancer gets worse or they develop intolerable side effects.
At the end of each cycle a physical examination, routine blood tests, and hormone levels will be performed.
After every 3 cycles, one or more of the following will be performed: bone scan, chest x-ray, CT scan or MRI.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Histologic documentation of adenocarcinoma of the prostate
- Bone metastasis(es) by bone scan or cat scan
- Clinical, biochemical, or radiographic progression after primary androgen ablation with either orchiectomy or gonadotropin releasing hormone analog therapy.
- One prior chemotherapy treatment is allowed.
- > 3 weeks since major surgery
- > 4 weeks since radiotherapy
- > 8 weeks since prior strontium-89 or samarium 153
- ECOG performance status 0 or 1
- Absolute neutrophil count (ANC) > 1,500/ul
- Platelets > 100,000/ul
- Bilirubin < 1.5 x upper limit of normal (ULN)
- AST or ALT < 3 x ULN
- Creatinine < 1.5 x ULN
- Electrolytes within 10% of normal range
- Serum testosterone < 50ng/dL
- Prostate-specific antigen (PSA) > 5.0ng/ml
Exclusion criteria
- Concomitant therapy with corticosteroids
- Chemotherapy within 28 days
- Currently active second malignancy other than non-melanoma skin cancer
- Baseline adrenal insufficiency requiring long-term steroids
Trial design
Primary purpose
Allocation
Interventional model
Masking
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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